Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
This study is currently recruiting participants.
Verified April 2013 by University of Massachusetts, Worcester
Sponsor:
University of Massachusetts, Worcester
Collaborator:
Information provided by (Responsible Party):
Xiaoduo Fan, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01578486
First received: April 11, 2012
Last updated: April 17, 2013
Last verified: April 2013
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Purpose
This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters.
Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder |
Drug: salsalate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Salsalate as an Adjunctive Treatment for Patients With Schizophrenia |
Resource links provided by NLM:
Further study details as provided by University of Massachusetts, Worcester:
Primary Outcome Measures:
- PANSS Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Positive and negative symptoms of schizophrenia will be measured by total score on Positive and Negative Syndrome Scale (PANSS).
- SANS Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Negative symptoms of schizophrenia will be measure by total score on the Scale for Assessment of Negative Symptoms (SANS)
- MATRICS Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment
Secondary Outcome Measures:
- HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Hemoglobin A1c (HbA1c) will be used to measure glucose levels. HbA1c will be measured as a percentage.
- Fasting Glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Fasting Blood Sugar levels will be measured
- Fasting Insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Fasting insulin levels will be measured by uUnits/ml.
- Lipid Profile [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride levels will be measured.
- hs-CRP [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation. Higher hs-CRP values correspond to higher levels of inflammation.
- TNF-alpha [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Tumor necrosis-alpha factor will be measured to assess inflammation levels.
- IL-6 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Interleukin-6 levels will be measured to detect inflammation
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: salsalate
open-label trial of salsalate 3g/day
|
Drug: salsalate
open-label trial of salsalate 3g/day for 12 weeks.
|
Detailed Description:
The specific aims include:
Primary aims:
- Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
- Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.
Secondary aims:
- Examine salsalate's effects on Hemoglobin A1c (HbA1c), fasting glucose, insulin and lipids.
- Examine salsalate's effects on high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18-65 years;
- Diagnosis of schizophrenia or schizoaffective disorder;
- Stable dose of the current antipsychotic drug for at least one month;
- Well established compliance with outpatient treatment per treating clinician's judgment;
- Able to complete the cognitive assessment battery (must be English speaking);
- Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
Exclusion Criteria:
- Inability to provide informed consent;
- Current substance abuse;
- Psychiatrically unstable per treating clinician's judgment;
- Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;
- Currently on immunosuppressant medication including oral steroids;
- Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);
- History of chronic infection (including, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition;
- Experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other NSAIDS;
- Pregnancy or breastfeeding;
- Pre-existing chronic tinnitus.
- Known hypersensitivity to salsalate.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578486
Contacts
| Contact: Matthew R Goodnow, BS | 508-856-2494 | Matthew.Goodnow@umassmed.edu |
Locations
| United States, Massachusetts | |
| University of Massaschusetts Medical School | Recruiting |
| Worcester, Massachusetts, United States, 01605 | |
| Principal Investigator: Xiaoduo Fan, MD | |
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
| Principal Investigator: | Xiaoduo Fan, MD, MPH, MS | UMass Medical School |
| Study Director: | Matthew R Goodnow, BS | UMass Medical School |
More Information
No publications provided
| Responsible Party: | Xiaoduo Fan, Principal Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT01578486 History of Changes |
| Other Study ID Numbers: | 2011-P-000798 |
| Study First Received: | April 11, 2012 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Massachusetts, Worcester:
|
Schizophrenia Cognition Metabolism Antipsychotics Psychopathology |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Sodium Salicylate Salicylsalicylic acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013